510(k) Report

Devices descending from K111230

122 later devices reach Synthes 3.5MM Low Profile Cortical Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—